BAriatric Surgery Induced Chromosomal Change

Obesity, Morbid Clinical Trial

— BASICC  

Official title:

Long-term Impact of Surgically Induced Rapid Weight Loss on Telomere Length and Its Potential Implications in the Genesis and Prevention of Neoplastic Disease Processes in Subjects With Severe Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903521
• Other study ID #: 23-488
• Status: Recruiting
• Start date: June 12, 2023
• Est. completion date: December 2023

Study information

• Verified date: September 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.

Description:

This study aims to evaluate the impact of metabolic and bariatric surgery on telomere length as well as the role of type 2 diabetes resolution and oxidative stress improvement on telomere lengthening.

The investigators hypothesize that metabolic and bariatric surgery is associated with the lengthening of telomeres as a possible underlying mechanism of cancer risk reduction.

It is a prospective, single-center study including patients with obesity class II or more (Body Mass Index ≥ 35kg/m2) and patients having had metabolic and bariatric surgery more than 12 months ago.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 126
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BMI = 35 kg/m2 without previous bariatric surgery (control group) OR

• Having had Sleeve Gastrectomy or Roux-en-Y Gastric Bypass more than 12 months ago and without a weight regain of = 15% of nadir weight (treatment group)

Exclusion Criteria:

• under 18 years of age

• no informed consent

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Locations

Country	Name	City	State
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Telomere length	Difference in terms of telomere length between patients with obesity class II or more (Body Mass Index [BMI] = 35kg/m2) and patients after metabolic and bariatric surgery.	1 day
Secondary	Metabolic disease remission (hypertension and type 2 diabetes remission versus no remission)	Evaluate if remission of metabolic disease (no remission versus remission) has an impact of metabolic disease remission on telomere length after bariatric and metabolic surgery	1 day
Secondary	Excessive weight loss (Weight loss [kg] / excess body weight [kg]) x 100 = Percent of excess body weight loss)	Evaluate if the amount of excessive weight loss has an impact on telomere length after bariatric and metabolic	1 day
Secondary	Lifestyle (Simple Lifestyle Indicator Questionnaire)	Evaluate if lifestyle (Simple Lifestyle Indicator Questionnaire) has an impact of lifestyle on telomere length after bariatric and metabolic	1 day
Secondary	Oxidative stress (Interleukin-1ß, Interleukin-6, TNF-a)	Evaluate if oxidative stress level (Interleukin-1ß, Interleukin-6, TNF-a) has an impact on telomere length after bariatric and metabolic	1 day